Tuesday, August 11, 2009
ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA IN PHARMACEUTICALS MANUFACTURING BY SURFACE SWAB METHOD
area by assesing the microbial contamination levels of any surface
against the predetermined action levels and efficiency of the operating
procedures in the aseptic areas during the manufacturing the product
UNIT OF RESPONSIBILITY:- QA Executive and trained QA Assistants
PRECAUTIONS:-
a) During the Swab testing the test portions are cleaned thoroughly with suitable
disinfactant to avoId contamination from the solutions used for the test
MATERIAL:-
1 Pre sterilized cotton buds/swabs
2 01 % w/v peptone water which has been previously sterilised
3 Sterilised molten soyabean casien digest agar maintained at a temperature
not below 45 degree C
Note :- The media preparation batch no is given to prepared media
PROCEDURE:-
1 Streak the cotton swab across the surface to be monitored
2 Monitor an area of approximately 100 sq cm with the swab being rotated so
that the entire bud/swab head is used
3 When the area of less than 100 sq cm is monitored due note should be made
of the comparison against the general specification Such monitoring may be
required in certain critical positions within aseptic areas
4 Use the last bud/swab of every set of buds/swabs as control and cross reference
with the sample as positive and negetive control
5 Transfer the swabs/buds into 10 ml of sterile 01 % peptone water
6 Prepare uniform suspension by rotating the tubes in between palms and 1 ml of this
suspension is poured in sterile empty plate Add to it 15 to 20 ml of sterile molten
soyabean casien digest agar
7 Incubate the plates, after solidifying of the medium in bacteriological incubator for 72
hours at 35 deg C to 37 deg C
8 Record the observations in the attachment 1
READING :-
The count is done as number of colony forming units (cfu) observed on the surface of
the agar after every 24 hours till completion of 72 hours of incubation
LIMITS :-1) Manufacturing area : wall : NMT 10 cfu Floor : NMT 20 cfu
2) Storage Area : wall : NMT 10 cfu Floor : NMT 20 cfu
3) Filling area : wall : NMT 05 cfu Floor : NMT 10 cfu
Note : In case the swab testing of the equipment is done after the sterilization
the count per swab should be Nil.
Standard operating procedure SOP for microbiology and aseptic techniques
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